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VEGF Trap in Treating Patients With Stage II or Stage III Multiple Myeloma That Has Relapsed or Not Responded to Previous Treatment
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008
Sponsors and Collaborators: Weill Medical College of Cornell University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00437034
  Purpose

RATIONALE: VEGF Trap may be able to carry cancer-killing substances directly to multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with stage II or stage III multiple myeloma that has relapsed or not responded to previous treatment.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: aflibercept
Procedure: flow cytometry
Procedure: immunoenzyme technique
Procedure: immunologic technique
Procedure: laboratory biomarker analysis
Procedure: pharmacological study
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Aflibercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase 2 Study of VEGF Trap (NSC 724770) for the Treatment of Relapsed or Refractory Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate (complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2007
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Evaluate the safety and efficacy of VEGF Trap in patients with relapsed or refractory, stage II or III multiple myeloma.
  • Evaluate the angiogenic properties of tissue for correlative studies in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically for correlative and pharmacokinetic studies. Samples are analyzed for biological markers and angiogenic profiles via immunoenzyme techniques and flow cytometry. Biomarkers may include vascular endothelial growth factor (VEGF) subtypes, platelet-derived growth factor, fibroblast growth factor, thrombopoietin, stromal-cell-derived factor, interleukin (IL)-6, IL-7, and VEGF receptor 1.

After completion of study treatment, patients are followed for 60 days and then periodically thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed multiple myeloma

    • Stage II or III disease according to Salmon-Durie staging criteria
  • Relapsed or refractory disease
  • Progressive disease
  • Measurable disease, defined by ≥ 1 of the following criteria:

    • Serum M protein ≥ 1.0 g/dL by serum protein electrophoresis
    • Free light chain measurement > 200 mg/dL
    • Urinary M protein excretion ≥ 200 mg/24 hours
  • Must have received ≥ 2 prior therapies* for multiple myeloma that meet the following criteria:

    • Antimyeloma therapeutic regimen consisting of ≥ 1 complete course of single-agent or combination-agent therapy, or a planned series of treatments (e.g., 3-4 courses of induction therapy followed by a stem cell harvest procedure followed by conditioning high-dose therapy supported by stem cell transplantation)
    • Antimyeloma regimen is discontinued because of the development of resistant disease or severe therapy-related toxicity
    • Individual antimyeloma regimen will be considered to have been discontinued when all agents of the regimen have been permanently stopped
    • A prior regimen will not be considered to have been discontinued for the modification of drug doses, or if less than all the agents of a combination regimen have been discontinued, or if the regimen has been halted temporarily for the development of a plateau phase of myeloma
    • Maintenance therapy will not be considered an additional regimen
    • If new agents are added to an existing regimen, presumably because of tumor resistance, the old regimen will be considered to have ended and a new regimen to have started NOTE: *If patients for religious or medical reasons are not able to receive approved therapies, they will be eligible for treatment after 1 prior therapy
  • No evidence of CNS disease, including primary brain tumor or brain metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
  • No albuminuria only

    • Urine protein:creatinine ratio < 1 OR 24-hour urine protein with an albumin level < 500 mg
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No known history of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in the study
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 28 days
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No clinically significant cardiovascular disease, including any of the following:

    • History of cerebrovascular accident within the past 6 months
    • Uncontrolled hypertension (i.e., blood pressure [BP] > 150/100 mm Hg or systolic BP > 180 mm Hg and diastolic BP < 90 mm Hg on ≥ 2 repeated determinations on separate days within the past 3 months)
    • Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
    • New York Heart Association class III or IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris within the past 6 months
    • Clinically significant peripheral vascular disease within the past 6 months
    • Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
  • No PT or INR > 1.5 (unless patient is on full-dose warfarin)
  • No evidence of bleeding diathesis or coagulopathy
  • No uncontrolled intercurrent illness that would limit compliance with study requirements, including ongoing or active infection
  • No psychiatric illness or social situations that would limit study compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • At least 48 hours since prior minor surgical procedures (e.g., bone marrow aspiration or biopsy, fine-needle aspiration, placement or removal of a central venous access device, or biopsy of a skin lesion)
  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior core biopsy
  • Concurrent full-dose anticoagulants (e.g., warfarin) with PT or INR >1.5 allowed provided the following criteria are met:

    • In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
    • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • No concurrent major surgery
  • No concurrent immunosuppressive agents (including steroids)
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437034

Locations
United States, New York
Don Monti Comprehensive Cancer Center at North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center     516-734-8900        
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C     212-305-8615        
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Janice L. Gabrilove, MD     212-241-9650     janice.gabrilove@mssm.edu    
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center     212-746-1848        
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Study Chair: Ruben Niesvizky, MD Weill Medical College of Cornell University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000530040, NYWCCC-0608008688
Study First Received: February 15, 2007
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00437034  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Study placed in the following topic categories:
Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009